EU Agrees to Amend AI Act, Restores High-Risk System Registration Requirement

The European Parliament and Council reached a provisional agreement on May 7, 2026 to reform the Artificial Intelligence Act as part of the Digital Omnibus on AI simplification package. The reform restores the obligation for providers to register AI systems in the EU's high-risk systems database and postpones the August 2, 2026 compliance deadline, setting December 2, 2027 for systems involving biometrics, critical infrastructure, education, employment, law enforcement and border management.

AI Act amendment agreement

• ▪The Council of the European Union said formal adoption of the Artificial Intelligence Act reform will take place in the coming weeks
• ▪The Artificial Intelligence Act reform is part of the Digital Omnibus on AI simplification package
• ▪The European Parliament and the Council of the European Union reached a provisional agreement to reform the Artificial Intelligence Act on May 7, 2026
• ▪The provisional agreement on the Artificial Intelligence Act reform needs to be endorsed and formally adopted by both the European Parliament and Council of the EU before it enters into law
• ▪Negotiations between the European Parliament and the Council of the European Union on the Artificial Intelligence Act reform were delayed one week before the May 7, 2026 agreement

Compliance deadline extensions

• ▪The Artificial Intelligence Act reform reduces the grace period for providers to implement transparency solutions for AI-generated content from six months to three months
• ▪The co-legislators intend to adopt the Artificial Intelligence Act reform before August 2, 2026, the start date for current rules on high-risk AI systems
• ▪The deadline for AI-generated content transparency solutions under the Artificial Intelligence Act reform is December 2, 2026
• ▪AI systems embedded in products will have an August 2, 2028 compliance deadline under the Artificial Intelligence Act reform
• ▪The Artificial Intelligence Act reform postpones the deadline for the establishment of AI regulatory sandboxes at the national level to August 2, 2027
• ▪AI systems involving biometrics, critical infrastructure, education, employment, law enforcement and border management will have a December 2, 2027 compliance deadline under the Artificial Intelligence Act reform
• ▪The Artificial Intelligence Act reform postpones the August 2, 2026 compliance deadline for high-risk AI systems

Sectoral overlap negotiations

• ▪The European Commission would be charged with creating implementing acts regarding potential overlap between the Artificial Intelligence Act and other sectoral laws including for medical devices, connected cars and toys
• ▪Machinery is exempted from direct Artificial Intelligence Act applicability where overlap exists with existing laws, with AI-specific health and safety handled through the Machinery Regulation
• ▪The European Commission would be able to adopt delegated acts to add health and safety requirements for AI systems that are deemed high risk under the Artificial Intelligence Act

Nudifier app ban

• ▪The Artificial Intelligence Act reform bans AI systems that create child sexual abuse material or use identifiable aspects of a person engaged in sexually explicit activities
• ▪Compliance with the prohibition on nudifier apps under the Artificial Intelligence Act reform starts December 2, 2026

High-risk system registration

• ▪The Artificial Intelligence Act reform brings back the obligation for providers to register AI systems in the EU's high-risk systems' database

Stakeholder reactions

• ▪DIGITALEUROPE argues that 95% of Europe's medtech companies are small-to-medium-sized enterprises and startups that will still face overlapping obligations under the Medical Device Regulation and the Artificial Intelligence Act
• ▪The Computer & Communications Industry Association said the Artificial Intelligence Act reform deal was a missed opportunity by not offering genuine simplification in key areas

Perspective of DIGITALEUROPE (industry group)

• ▪DIGITALEUROPE argues that 95% of Europe's medtech companies are small-to-medium-sized enterprises and startups that will still face overlapping obligations under the Medical Device Regulation and the Artificial Intelligence Act